News from the eCF

MEMBERS ONLY

eCF Members Release 27-April-2018

The eClinical Forum is happy to announce the Members-Only release of the “eCF Requirements”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.

The eCF Requirements are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. We have reviewed regulatory documents from the FDA, EMA, PMDA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if data which will become part of a regulated clinical trial are consistent with regulatory requirements.

Selected events are recorded and are available un-edited for member use only within the "BoF & TS Recordings" folder below. Not all events will be recorded or released. Recordings are un-edited and are provided for eCF member use only. Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors.

eCF Technology Showcase: 16-Feb-2017 - Registration Required

The use of wearable sensors in the clinical trial marketplace is growing rapidly. These solutions have the ability to provide valuable patient contextual information in near real time and offer the possibility to improve clinical trial efficiency and understanding of clinical outcomes.

Discussion and demonstration facilitated by Jeremy Wyatt of Actigraph;

Not a member?
Visit the Membership page to learn How To Become a Member (Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)

Sponsors & CROs -- Please take a few minutes to complete this brief survey regarding how your company reviews site healthcare systems. We would like the input of every company whether you are using eSRA or your own assessment or not assessing at all.

The link/survey will only be active until the end of May 2019, but we encourage you to complete the survey before Friday, February 22 2019, as we need the information to improve the eSRA Version 2019 which will be available the first week of March. Responses after Feb 22, 2019 will be considered for the 2020 version.

Sites -- If you would like to provide feedback for the eSRA V2019, please describe your feedback in an email to esra@eclinicalforum.org

Save the Date!! Please join us for our Spring meeting. Agenda topics will be announced in Feb 2019. All suggestions welcome -- please email Suzanne Bishop at webmaster3@eclinicalforum.org to suggest topics or get registration information.

Our European meeting of the eClinical Forum will take place in Brussels 15-17 May 2019.

Come along and see why our members are so excited... "ECF are the only meetings I attend each year. It gives me everything I need to stay current and to answer my questions" "People were amazing. Topics were great"